Coronary Angiography Via Femoral Artery Access
Conditions
Keywords
CAG
Brief summary
Is the FemoSeal® closure device safer and more comfortable than manual compression for femoral artery access closure after coronary angiography?
Detailed description
Access site complication after coronary angiography is still a challenge in everyday practice. The FemoSeal® closure device has proven very safe as shown in the swedish SCAAR registry. This study is aimed to investigate, in a randomized design, if the FemoSeal® has an advantage in safety and efficacy over manual compression.
Interventions
DEVICEFemoSeal®
Closure device for femoral artery access closure
OTHERManual compression
Conventional manual compression
Sponsors
Vingmed Danmark A/S
Aarhus University Hospital Skejby
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The patient must be at least 18 years old * Patients undergoing femoral access coronary angiography * Patient must be competent for providing informed, written consent * Only 6F sheath
Exclusion criteria
* Percutaneous coronary intervention * Intra coronary measurements (FFR, IVUS, OCT, NIR) * Groin hematoma before closure * Pseudoaneurysm or AV fistula * Significant stenosis of ilial or femoral artery * Prior peripheral artery surgery * INR \> 3,0 * Platelet count \< 120 million per millilitre blood * Coagulopathy (bleeding disorder) * Thrombolysis in the last 24h * Planned heparin infusion after the procedure * Pregnancy * Uncontrolled hypertension \> 200 mmHg / 110 mmHg * Femoral access device closure in the last 30 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of ipsilateral palpable groin hematomas with largest diameter exceeding 5 cm. | 20 minutes, 1 hour and at discharge, pooled |
Secondary
| Measure | Time frame |
|---|---|
| Composite of: major vascular complications necessitating surgical repair, A-V fistulation, pseudoaneurysm needing treatment, major bleeding needing transfusion and infection needing antibiotics . | 14 days |
| Time to hemostasis, from sheath removal to hemostasis is achieved | 14 days |
| Time from end of closure procedure to ambulation. 1h bedrest recommended. | 14 days |
| Device deployment failure | 20 minutes |
| Rate of ipsilateral palpable groin hematomas with largest diameter exceeding 5 cm. Patient self-measurements. | 14 days |
| Need for repeated manual compression after end of the closure procedure | 14 days |
| Pain and discomfort measured on a numerical pain rating scale (0-10) | 20 min |
| Vasovagal reaction (clinical signs AND Systolic BP drop of more than 30 mmHg AND/OR pulse drop more than 30 b/min. AND reversible immediately after treatment by atropin, fluids) | 20 minutes |
| The patient seeking medical assistance for all-cause closure site related symptoms after discharge. | 14 days |
| Time to cessation of continuous minor oozing measured from the end of the closure procedure | 14 days |
Countries
Denmark
Outcome results
None listed